Libertas E-XLPE Modular Liner

Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented

Maxx Orthopedics, Inc.

The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Libertas E-xlpe Modular Liner.

Pre-market Notification Details

Device IDK192989
510k NumberK192989
Device Name:Libertas E-XLPE Modular Liner
ClassificationHip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Applicant Maxx Orthopedics, Inc. 2460 General Armistead Ave, Suite 100 Norristown,  PA  19403
ContactPriscilla Herpai
CorrespondentPriscilla Herpai
Maxx Orthopedics, Inc. 2460 General Armistead Ave, Suite 100 Norristown,  PA  19403
Product CodeOQI  
Subsequent Product CodeLZO
Subsequent Product CodeOQG
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-25
Decision Date2020-10-29

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